BEUDAMED
    FDA Enforcement Class II Terminated

    Tissu-Trans Filtron 1000 Catalog Number 3-TT-FILTRON 1000. Used for fat transfer and liposuction.

    Recall: Z-0170-2018 · Reported November 29, 2017

    Enforcement

    Recall Number
    Z-0170-2018
    Event ID
    78392
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Shippert Medical Technologies
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 29, 2017
    Initiation Date
    October 20, 2017
    Classification Date
    November 22, 2017
    Termination Date
    October 9, 2018
    Address
    6248 S Troy Cir Ste A, N/A, Centennial, CO, 80111-6485, United States

    Description

    Tissu-Trans Filtron 1000 Catalog Number 3-TT-FILTRON 1000. Used for fat transfer and liposuction.

    Reason

    Potential breach of sterility of the packaging.

    Code Info

    Lot 12004

    Distribution

    Worldwide Distribution -- United States, Australia, and Netherlands.

    Quantity

    56 units